Submission of Petitions: Food Additive, Color Additive (Including Labeling), and Generally Recognized as Safe Affirmation; and Electronic Submission Using FDA Forms 3503 and 3504

Forms and Documents

Document Name	Status
SS-0910-0016#2.doc Supporting Statement A	2011-03-25

IC Document Collections

IC ID	Document Title	Status
5672	Submission of Petitions, Color Additive Including Labeling Other-Instructions	Modified
180098	Form FDA 3503 Instruction	Modified
180097	Submission of Petitions: Food Additive Including Labeling Instruction	Modified
180096	Submission of Petitions Generally Recognized As Safe Affirmation Instruction	Modified

ICR Details

OMB Control No: 0910-0016	ICR Reference No: 201104-0910-003
Status: Historical Active	Previous ICR Reference No: 200705-0910-002
Agency/Subagency: HHS/FDA	Agency Tracking No:
Title: Submission of Petitions: Food Additive, Color Additive (Including Labeling), and Generally Recognized as Safe Affirmation; and Electronic Submission Using FDA Forms 3503 and 3504
Type of Information Collection: Reinstatement with change of a previously approved collection	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Approved without change	Conclusion Date: 06/27/2011
	Date Received in OIRA: 04/12/2011
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	06/30/2014	36 Months From Approved
Responses	12	0	0
Time Burden (Hours)	26,573	0	0
Cost Burden (Dollars)	5,600	0	0

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Abstract: Currently, interested persons may transmit regulatory submissions to the Office of Food Additivie Safety in the Center for Food Safety and Applied Nutrition using Form FDA 3504 for color additive petitions. FDA is revising Form FDA 3503 to better enable its use for electronic submission and to permit its use for multiple types of submissions, which eliminates the need for Form FDA 3504. This action is a consolidation of Form FDA 3504 under Form FDA 3503, which after OMB approval for this request Form FDA 3504 will be discontinued. In summary, the revised Form FDA 3503 will be used for food additive and color additive petitions.

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Authorizing Statute(s): US Code: 21 USC 348 Name of Law: FFDCA
  

Citations for New Statutory Requirements: None

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Associated Rulemaking Information
RIN:	Stage of Rulemaking:	Federal Register Citation:	Date:
	Not associated with rulemaking

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Federal Register Notices & Comments
60-day Notice:	Federal Register Citation:	Citation Date:
	75 FR 33624	06/14/2010
30-day Notice:	Federal Register Citation:	Citation Date:
	75 FR 52954	08/30/2010
Did the Agency receive public comments on this ICR? No

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Number of Information Collection (IC) in this ICR: 4

IC Title	Form No.	Form Name
Submission of Petitions, Color Additive Including Labeling	3503	Food Additive; Color Additive Petition; Food Master File; Color Master File
Submission of Petitions Generally Recognized As Safe Affirmation	3503	Food additive Petition; Color Additive Petition;; Food Master File; Color Master File
Submission of Petitions: Food Additive Including Labeling	3503	Food additive Petition; Color Additive Petition; Food Master File; Color Master file
Form FDA 3503	3503	Food Additive Petition; Color Additive Petition; Food Master File; Color Master File

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ICR Summary of Burden

	Total Approved	Previously Approved	Change Due to New Statute	Change Due to Agency Discretion	Change Due to Adjustment in Estimate	Change Due to Potential Violation of the PRA
Annual Number of Responses	12	0	0	0	0	12
Annual Time Burden (Hours)	26,573	0	0	-22,613	0	49,186
Annual Cost Burden (Dollars)	5,600	0	0	-2,600	0	8,200

Burden increases because of Program Change due to Agency Discretion: Yes

Burden Increase Due to: Miscellaneous Actions

Burden decreases because of Program Change due to Agency Discretion: Yes

Burden Reduction Due to: Miscellaneous Actions

Short Statement: Form FDA 3504 is being consolidated under Form FDA 3503. The revised Form FDA 3503 is formatted to accept submissions for both food additive and color additive petitions. thus making redundant Form FDA 3504. Upon approval of this revised collection, Form FDA 3504 will be discontinued. As a result FDA has recognized a decrease in burden and cost estimates as explained in item 15 of the supporting statement.

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Annual Cost to Federal Government: $935,498

Does this IC contain surveys, censuses, or employ statistical methods? No

Is the Supporting Statement intended to be a Privacy Impact Assessment required by the E-Government Act of 2002? No

Is this ICR related to the Affordable Care Act [Pub. L. 111-148 & 111-152]? No

Is this ICR related to the Dodd-Frank Wall Street Reform and Consumer Protection Act, [Pub. L. 111-203]? No

Is this ICR related to the American Recovery and Reinvestment Act of 2009 (ARRA)? No

Is this ICR related to the Pandemic Response? Uncollected

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Common Form ICR:  No

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On behalf of this Federal agency, I certify that the collection of information encompassed by this request complies with 5 CFR 1320.9 and the related provisions of 5 CFR 1320.8(b)(3).

The following is a summary of the topics, regarding the proposed collection of information, that the certification covers:

(a) It is necessary for the proper performance of agency functions;

(b) It avoids unnecessary duplication;

(c) It reduces burden on small entities;

(d) It uses plain, coherent, and unambiguous language that is understandable to respondents;

(e) Its implementation will be consistent and compatible with current reporting and recordkeeping practices;

(f) It indicates the retention periods for recordkeeping requirements;

(g) It informs respondents of the information called for under 5 CFR 1320.8 (b)(3) about:

(i) Why the information is being collected;

(ii) Use of information;

(iii) Burden estimate;

(iv) Nature of response (voluntary, required for a benefit, or mandatory);

(v) Nature and extent of confidentiality; and

(vi) Need to display currently valid OMB control number;

(h) It was developed by an office that has planned and allocated resources for the efficient and effective management and use of the information to be collected.

(i) It uses effective and efficient statistical survey methodology (if applicable); and

(j) It makes appropriate use of information technology.

If you are unable to certify compliance with any of these provisions, identify the item by leaving the box unchecked and explain the reason in the Supporting Statement.

Certification Date: 04/12/2011

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